Report Writer
- Hiring from
- United Kingdom, United States
- Work type
- Remote
- Posted
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- Have a good knowledge of the appropriate GLP/GCP standards and latest regulatory guidelines, to include 21CFR Part 11.
- Be familiar with, and work in accordance with, SOPs and Study Documents.
- Complete all paperwork in compliance with good record keeping principles; correctly and on time in compliance with GLP/GCP and in accordance with Good Documentation Practices (GDP).
- Prepare documents in accordance with requirements. Be able to effectively communicate findings and summaries from study data.
- Utilize LIMS and other data systems to prepare data, chromatograms, tables, and figures for inclusion in reports.
- Work with scientific teams regarding technical and study details.
- Responsible for overseeing report lifecycle, addressing QA audits, and submission of reports to clients.
- Be flexible; realise that timelines, priorities and requirements will change regularly and respond to these challenges accordingly.
- Ability to plan and organise your work, while being aware of required timelines. Manage your own time and challenge yourself to identify and champion process improvement opportunities
- Make suggestions for how processes can be improved and efficiency maximised, to include revising and/or creating report templates, lab manuals and other items as needed.
- BA/BS in a science or related field preferred; all experiences will be evaluated
- Knowledge and understanding of regulatory requirements; GLP, GCP, 21CFR Part 11, GDP, GMP.
- Demonstrated knowledge of scientific or technical writing, with proven written skills
- Able to work in a regulated environment
- Able to work effectively and contribute within a team
- Able to work with computer systems; in-depth knowledge of Microsoft Office.
- Able to document clearly